This invention relates to a gastropexy kit having at least one hollow needle configured to hold a fastener. The fastener is held in a shaft of a needle. The fastener desirably has a suture coupled thereto and, near an opposite end, a suture holder, for use in a percutaneous fixation of a patient's stomach.
Health care providers are at risk of exposure to blood-borne pathogens, including, for example, hepatitis B, hepatitis C, HIV, and the like. The risk of an accidental stick from a sharp object, such as a needle, exists in many medical procedures. One such procedure is gastropexy, in which a needle is used to pierce a patient's abdominal wall to place one or more fasteners in a patient's stomach. Such a needle must be sharp, so that it penetrates through the patent's skin and abdominal wall to the stomach. A fastener, such as a “T-bar” fastener, carried at or near the tip of the needle is desirably deployed by the needle so that it can be positioned against an inner wall of the stomach. A tensioning suture is connected to the fastener and, at an opposite end of the suture on the outer surface of the patient's body, the suture is desirably also connected to a suture holder, which permits adjustment of the tension on the suture. In this manner, when the suture is tensioned a patient's stomach wall is more closely positioned to the outer surface of the patient's body, and the stomach is stabilized in a position. Usually, at least three and desirably four fasteners are placed in a triangular, square, or diamond-shaped configuration through a patient's skin and into the stomach. Gastropexy is used to isolate and stabilize a portion of a patient's stomach, so that a tissue opening or stoma may be created in the middle of the triangular, square or diamond configuration of fasteners and suture holders, to permit placement of a feeding tube, and so forth.
After each fastener is positioned by a needle, the needle still remains as a sharp hazard, in its position inside of the patient's stomach, as well as when it is removed therefrom. Therefore, there is a need to provide an apparatus which permits blunting of the needle after the fastener is deployed from the needle. Desirably, the needle may be blunted while it is still in a position in the patient's stomach. Further, it is desirable that a health care provider easily detect whether the needle has been blunted once a safety apparatus has been activated. Once activated, the blunting safety apparatus desirably may not be deactivated, so that the needle could not be rendered a sharp hazard again. Finally, such a blunting safety apparatus is desirably activated by a single-handed technique, i.e., the hand holding a proximal end of the needle, thereby allowing the health care provider's hands to remain away from a sharp distal end of the needle during such activation of a safety blunting apparatus.
It is also desirably to provide a method and apparatus so that the plurality of fasteners deployed in a patient's stomach do not need to be removed via an invasive method after gastropexy. As noted, during a gastropexy procedure, it is desirable to place three or four fasteners against a patient's stomach wall. Once a stoma is created, it is desirable to keep the fasteners, suture and suture holder in a position for two to three weeks, so that the stoma becomes well stabilized, and so that gastric liquids, and so forth, do not contaminate and cause infection in a patient's peritoneal cavity. Removing the fasteners after the requisite stabilization time, however, can be problematic.
Sometimes a needle apparatus is used to follow the suture back through a patient's skin to attempt to percutaneously retrieve each fastener. Such a procedure causes new trauma, with new risks of infection. Alternatively, laproscopic methods are used to retrieve each fastener. Such a procedure often involves anesthesia, and again may cause trauma in a patient's mouth, esophagus, and/or stomach.
It would be desirably to use a resorbable suture with the fastener. Such a resorbable suture would crimp or otherwise couple to the fastener at one end, and desirably, a suture holder at an opposite end. The suture would be absorbed by the patient's body after the critical two to three week period. Therefore, no invasive procedure would be required to remove the fasteners. The fasteners would fall away from a wall of the stomach, and follow a patient's digestive tract to be expelled.
The suture holder on a patient's skin is also part of the gastropexy procedure. In some instances, a suture holder is not used, and the opposite end of the suture, which extends to the patient's skin, is temporarily stitched to the patient's skin. In other procedures, the external opposite end of the suture is clamped via an external retention device that usually includes a cotton ball, a plastic washer, plastic tubing, and one or more metal crimps. There are problems with both of these external suture retention methods.
Patients dislike having external stitches, which can pull against the skin, or catch on clothing or gowns. Further, additional suturing requires additional skill and safety risks for the physician. Moreover, after external sutures are in place, there may be confusion as to why the sutures are present. There is a risk that a health care provider, as a result of this confusion, will try to cut and pull out the external suture(s). Issues also exist with retention devices.
One retention device, described above, has many drawbacks. It cannot easily be cleaned. That is, the cotton ball, which is positioned against the patient's skin, may easily harbor bacteria and microorganisms, and may be difficult to change. Further, the device uses plastic tubing, washers, and metal crimps. The combination of components in this retention device results in a high profile away from the skin, typically 0.75 inches or more. These devices may pull, catch on clothing, or rub against the skin, causing abrasion or necrosis due to pressure.
There exists a need for a suture retention hub that has a low profile against a patient's skin. Such a device would be easily recognizable to health care provider as a retention hub for anchoring an internally disposed device via a suture. The hub would desirably by formed from a material which has excellent biocompatibility and ease of cleaning. Such a material would desirably be soft and provide cushioning against a patient's skin, to prevent abrasion and/or necrosis. Such a hub would permit an adequate retention force, and desirably would permit easy tensioning of the suture by a simple manipulation of the hub.
Definitions
As used herein, the term “stylus” refers to a solid or hollow rod which has a blunted, non-sharp distal end, which is sized to fit and move within and extend through at least a sharp end of a hollow needle. The stylus is desirably, but not by way of limitation, made from the same material as the sharp end of the needle. However, the stylus may be made from any material(s) so long as it operates as shown and/or described herein.
As used herein, the terms “comprise”, “comprises”, “comprising” and other derivatives from the root term “comprise” are intended to be open-ended terms that specify the presence of any stated features, elements, integers, steps, or components, but do not preclude the presence or addition of one or more other features, elements, integers, steps, components, or groups thereof. Similarly, the terms “include”, “includes”, “has” and/or “have”, and derivatives thereof, are intended to be interpreted as the word “comprise”, and are intended to be open-ended terms that specify the presence of any stated features, elements, integers, steps, or components, but do not preclude the presence or addition of one or more other features, elements, integers, steps, components, or groups thereof.
As used herein, the terms “resilient”, “resilience” and/or “resiliency” and any derivatives thereof refers to the physical property of an object and/or a material that can return to its original form, shape and/or position after deformation such as being bent, compressed, or stretched that does not exceed its elastic limit.
As used herein, the term “couple” includes, but is not limited to, joining, connecting, fastening, linking, or associating two things integrally or interstitially together.
As used herein, the term “configure” or “configuration”, and derivatives thereof means to design, arrange, set up, or shape with a view to specific applications or uses. For example: a military vehicle that was configured for rough terrain; configured the computer by setting the system's parameters.
As used herein, the terms “substantial” or “substantially” refer to something which is done to a great extent or degree; a significant or great amount; for example, as used herein “substantially” as applied to “substantially” covered means that a thing is at least 70% covered.
As used herein, the term “alignment” refers to the spatial property possessed by an arrangement or position of things in a straight line or in parallel lines.
As used herein, the terms “orientation” or “position” used interchangeably herein refer to the spatial property of a place where or way in which something is situated; for example, “the position of the hands on the clock.”
As used herein, the term “about” refers to an amount that is plus or minus ten (10) percent of a stated number or a stated or implied range.
These terms may be defined with additional language in the remaining portions of the specification.